Cosmetic and/or pharmaceutical compositions and their applications

ABSTRACT

Compositions are disclosed containing, as active ingredients, an extract of  Allium  species, an extract of  Citrus  species and either an extract of  Paullinia  species and an extract of  Theobroma  species, or an extract of  Salix  species and zinc sulphate, and the method of preparation of these compositions, and cosmetic and/or pharmaceutical application of these compositions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 12/526,493, filed onAug. 7, 2009, which is a national phase of and claims priority toInternational Application No. PCT/FR2008/000152, filed on Feb. 8, 2008,which claims priority to French Patent Application Serial No. 07 01 011,filed on Feb. 13, 2007, all of which are incorporated by referenceherein.

BACKGROUND AND SUMMARY

The invention concerns new compositions and the use of thesecompositions in cosmetics and/or their application as medicines.

Some cosmetic and/or pharmaceutical compositions containing fresh onion,iodine salts, citric acid and lemon juice have been described in theliterature. These compositions can be used especially in cosmetics toencourage the regrowth of hair or in therapeutical indications topromote angiogenesis, stimulate the synthesis of collagen and stimulatethe proliferation and activation of mast cells, and indeed in thetreatment of certain cancers. Among the literature references that maybe cited, for example, are the French patent applications No. 2 875 403,2 877 219, 2 877 224, 2 877 576 and 2 877 408 or the Swiss patentapplication No. 682 217 A. The applicant has studied new compositionswhich are suitable for use in cosmetics or human therapy and which showsuperior activity and high stability without the disadvantages of thecompositions described in the literature.

The object of the invention is thus new compositions characterised bythe fact that they contain: an extract of Allium species, an extract ofCitrus species and

-   -   either an extract of Paullinia species and an extract of        Theobroma species    -   or an extract of Salix species and zinc sulphate.        Among these compositions, those which are of more particular        interest are compositions as defined above, characterised in        that they contain: an aqueous-alcoholic extract of Allium        species, an aqueous-alcoholic extract of Citrus species and    -   either an aqueous-alcoholic extract (atomised or not) of        Paullinia species and an aqueous-alcoholic extract (atomised or        not) of Theobroma species,    -   or an aqueous extract (atomised or not) of Salix species and        zinc sulphate.

Among the compositions according to the invention, those which are ofmost particular interest are compositions as defined above, containingfrom 65% to 93% of an aqueous-alcoholic extract of Allium species, from5% to 33% of an aqueous-alcoholic extract of Citrus species, from 0.25%to 2.5% of an aqueous-alcoholic extract (atomised or not) of Paulliniaspecies and from 0.25% to 2.5% of an aqueous-alcoholic extract (atomisedor not) of Theobroma species and especially those containing from 65% to93% of an aqueous-alcoholic extract of Allium cepa, from 5% to 33% of anaqueous-alcoholic extract of Citrus lemon, from 0.25% to 2.5% of anaqueous-alcoholic extract (atomised or not) of Paullinia species andfrom 0.25% to 2.5% of an aqueous-alcoholic extract (atomised or not) ofTheobroma species. The term extract of Allium species oraqueous-alcoholic extract of Allium species refers particularly toaqueous-alcoholic extracts and native extracts obtained from all speciesof the genus Allium (family Liliaceae) and especially Allium cepa.Extract of Citrus species or aqueous-alcoholic extract of Citrus speciesrefers particularly to aqueous-alcoholic extracts and native extractsobtained from all species of the genus Citrus (family Rutaceae) andespecially Citrus lemon. Extract (atomised or not) of Paullinia speciesor aqueous-alcoholic extract (atomised or not) of Paullinia speciesrefers particularly to aqueous-alcoholic extracts and native extractsobtained from all species of the genus Paullinia (family Sapindaceae)and especially Paullinia cupana. Extract (atomised or not) of Theobromaspecies or aqueous-alcoholic extract (atomised or not) of Theobromaspecies refers particularly to aqueous-alcoholic extracts and nativeextracts obtained from all species of the genus Theobroma (familyMalvaceae) and especially Theobroma cacao.

Among the compositions according to the invention, those which are alsoof most particular interest are compositions as defined above containingfrom 65% to 93% of an aqueous-alcoholic extract of Allium species, from5% to 33% of an aqueous-alcoholic extract of Citrus species, from 0.25%to 2.5% of an aqueous extract (atomised or not) of Salix species andfrom 0.1% to 1% of zinc sulphate, and especially those containing from65% to 93% of an aqueous-alcoholic extract of Allium cepa, from 5% to33% of an aqueous-alcoholic extract of Citrus lemon, from 0.25% to 2.5%of an aqueous extract (atomised or not) of Salix species and from 0.1%to 1% zinc sulphate hexahydrate. Extract of Salix species or aqueousextract (atomised or not) of Salix species refers to aqueous extractsobtained from all species of the genus Salix (family Salicaceae),especially Salix alba. The zinc sulphate used in compositions accordingto the invention may be in the form of the anhydrous salt or apolyhydrated salt, especially the hexahydrate.

The most preferred compositions according to the invention are:

-   -   those containing approximately 87% of an aqueous-alcoholic        extract of Allium cepa, approximately 12% of an        aqueous-alcoholic extract of Citrus lemon, approximately 0.5% of        an aqueous-alcoholic extract (atomised or not) of Paullinia        cupana and approximately 0.5% of an aqueous-alcoholic extract        (atomised or not) of Theobroma cacao,    -   as well as those containing approximately 87% of an        aqueous-alcoholic extract of Allium cepa, approximately 12% of        an aqueous-alcoholic extract of Citrus lemon, approximately 0.5%        of an aqueous extract (atomised or not) of Salix alba and 0.2%        zinc sulphate hexahydrate.        Another object of the invention is a method for the preparation        of compositions such as those defined above, involving the        preparation of a master solution containing the extracts of        Allium species and Citrus species and then mixing this solution        either with an extract of Paullinia species and an extract of        Theobroma species, or with an extract of Salix species and zinc        sulphate, to give the required composition.

According to the preferred conditions for carrying out this process, themethod is characterised in that the master solution is prepared bypicking, cleaning and milling the Allium and the Citrus, macerating forseveral hours in alcohol and filtering, then adjusting the alcoholicextract and mixing with the other ingredients. In using this method ofpreparation for the compositions according to this application, arecommended procedure is to prepare the master solution from theconstituents, by picking, cleaning and milling the Allium and theCitrus, mixing with 96° alcohol, macerating in the cold for 48 hours,filtering the master solution through 0.22-micron filters to give awater-alcohol extract with a low content of particles and then adjustingthe extract obtained to 30° alcohol. This master solution is thentreated, by simple mixing, either with the extracts (atomised or not) ofPaullinia species and Theobroma species, or with the extract (atomisedor not) of Salix species plus the zinc sulphate.

Compositions such as those described above exhibit interestingproperties which make them suitable for use in cosmetics. In cosmeticapplications, these compositions may be used in particular forcontrolling and/or stabilising any conditions affecting the skin, thescalp or other external parts of the body, and especially for slowingdown the loss of hair, stimulating its growth, increasing its density,eliminating dandruff, offsetting the signs of ageing of the scalp andtreating any disorders of the nails. For topical application, thesecompositions may thus be applied directly to the skin or the scalp atthe rate of one to three applications daily in the form of solutions orconcentrated lotions, for example, with a concentration of 5 to 30%,preferably approximately 20%. For cosmetic applications, thecompositions may also be administered as food supplements in the form ofgranules, flexible capsules or drinks; depending on the final formrequired, and instead of using the product in the form of an aqueousalcoholic solution, it may be better to use the product as a dry formobtained from the solution, for example by atomisation, freeze-drying,concentration or secondary extraction of the aqueous-alcoholic solutionwith super-critical CO₂.

Compositions such as those described above also show very interestingpharmacological properties. They may therefore be administered to humansor animals as medicines, especially as therapeutic or prophylacticmedicines. In particular, these compositions may be used for treatingdermatosis, and more particularly dermatosis due to various cutaneousbacterial and viral infections, ageing of the skin, bleaching andwhitening of the skin, vitiligo, acrodermatitis, light-induced (actinic)ageing of the skin and various conditions related to sunrays(photodermatosis), acne of any origin (vulgaris, inflammatory or papulopustule), acne rosacea, lupus erythematosus, sensitive skin, insectstings, oily or dry skin, seborrheic disorders, alopecia of any origin,hair loss, pityriasis capitis, pelada, sensitive scalp, greasy hair,psoriasis and parapsoriasis of the scalp, dyshidrosis, warts and corns,scabies, angular cheilitis and oedema, or any diseases capable ofaffecting the nails.

In therapy, these compositions also have an effect onmicrovascularisation and an effect on the cicatrisation of wounds,affections of any origin, burns, blotchiness, Behçet's disease,cutaneous porphyria, angiomas and malignant metastases. They may also beused in therapy for treating disorders of keratinisation, as well askeratotic lesions, hyperkeratoses including keratoderma, dyskeratosis,Darier's disease, parakeratosis, ichthyosis, eczema, neurodermatitis,erythroderma, lichenification, scaly dermatosis, prurigo, cheloids andpustulosis. Finally they may be used in therapy for treating circulatoryand vasomotor disorders, especially the functional signs duringhaemorrhoidal pressure, thrombotic affections, symptoms associated withveno-lymphatic insufficiency, heavy legs and paresthesia.

The compositions may be administered as such or in mixtures with one ormore other compounds in the form of pharmaceutical compositionscontaining an effective dose as the active ingredient, together withstandard, pharmaceutically inert excipients and/or additives. Thesepharmaceutical compositions may be administered by the buccal, enteralor parenteral routes, by local topical application to the skin and themucosa, or by injection, for example by subcutaneous injection. Themedicines may also be given orally, for example in the form of tablets,coated tablets, film-coated forms, granules, capsules, soft capsules,solutions, syrups, emulsions, suspensions or aerosol mixtures. As statedabove, depending on the form required, it will be best to use theproduct in the form of an aqueous-alcoholic solution or as a dry form.Administration is also possible by the rectal route, for example, in theform of suppositories, or by the parenteral route, for example in theform of injectable solutions or infusions, microcapsules or implants, bythe percutaneous route, for example, in the form of ointment, solutions,pigments or colourings, by the transdermal route (patches) or by otherroutes such as those involving aerosols or nasal sprays.

These pharmaceutical compositions are prepared by conventional methods,in which pharmaceutically inert, organic or inorganic excipients areadded to the compositions obtained according to the invention. Thesecompositions may therefore be solids or liquids, presented in any of thepharmaceutical forms commonly used in human medicine, as for exampleplain or sugar-coated tablets, pills, lozenges, capsules, drops,granules, injectable preparations, ointments, creams or gels, preparedby standard methods. For the production of plain or sugar-coatedtablets, coated tablets and hard gelatin capsules it is possible to use,for example, lactose, corn starch or derivatives thereof, talcum andstearic acid or its salts.

Suitable carriers for soft gelatin capsules or for suppositoriescomprise for example, fats, waxes, semi-solid or liquid polyols, naturalor modified oils, etc. Suitable vehicles for the preparation ofsolutions, for example, injectable solutions, emulsions or syrups,comprise, for example, water, alcohols, glycerol, polyols, sucrose,invert sugars, glucose, vegetable oils, etc. Suitable carriers formicrocapsules or implants comprise, for example, copolymers of glyoxalicacid and lactic acid. The active ingredients as defined above may beblended with the excipients usually employed in pharmaceuticalcompositions, such as talcum, gum arabic, lactose, starch, magnesiumstearate, cocoa butter, aqueous or non-aqueous vehicles, fattysubstances of animal or vegetable origin, paraffin derivatives, glycols,various wetting agents, dispersants or emulsifiers and preservatives. Inaddition to the active ingredients as defined above and the excipients,pharmaceutical compositions may contain additives such as, for example,diluents, disintegrators, binders, lubricants, wetting agents,stabilisers, emulsifiers, preservatives, sweeteners, colorants, flavoursor fragrances, thickeners and buffering agents, and also solvents orsolubilisers, retarders, osmotic pressure-modifying salts, coatingmaterials or antioxidants. This invention also includes pharmaceuticalcompositions containing at least one of the drugs defined above asactive ingredient.

When using the compositions obtained according to the invention, dosesmay vary within relatively wide limits and must be set according to theperson being treated and the condition concerned. Pharmaceuticalcompositions normally contain from 0.2 to 500 mg, preferably from 1 to200 mg, of active ingredients as defined above, in the form of dryextract. For oral administration, the daily dose generally variesbetween 0.05 and 10 mg/kg, preferably from 0.1 to 8 mg/kg, particularlyfrom 0.1 to 6 mg/kg. For example, a daily dose varying from 5 to 500 mgwould be appropriate for an adult. For intravenous administration, thedaily dose varies approximately from 0.05 to 6 mg/kg, preferably from0.1 to 5 mg/kg. The daily dose may be divided, especially when a largeamount of active ingredient is to be administered.

DETAILED DESCRIPTION

Some examples will now be given below so as to illustrate theimplementation of the invention in a non-restrictive manner. In view ofthe nature of the products, a fragrance or perfume should obviously beadded when they are to be used in liquid or solid form.

Examples Example 1

A composition was prepared containing:

an aqueous-alcoholic extract of Allium cepa: 87.04% an aqueous-alcoholicextract of Citrus lemon: 11.96% an atomised aqueous-alcoholic extract ofPaullinia cupana: 0.50% an atomised aqueous-alcoholic extract ofTheobroma cacao: 0.50%

The aqueous-alcoholic extract of Allium cepa was prepared by picking,cleaning and milling the Allium, macerating in 96° alcohol for 48 hoursin the cold, filtering through a 0.22-micron filter, collecting thealcoholic filtrate and adjusting to 30° alcohol.

The aqueous-alcoholic extract of Citrus lemon was prepared by picking,cleaning and milling the Citrus, macerating in 96° alcohol for 48 hoursin the cold, filtering through a 0.22-micron filter, collecting thealcoholic filtrate and adjusting to 30° alcohol.

A master solution containing the aqueous-alcoholic extracts of Alliumand Citrus was prepared by simple mixing, then the atomisedaqueous-alcoholic extracts of Paullinia cupana and Theobroma cacao wereadded to this master solution to give the required combined extract.

Example 2

A composition was prepared containing:

an aqueous-alcoholic extract of Allium cepa: 87.30% an aqueous-alcoholicextract of Citrus lemon: 12.00% an atomised aqueous extract of Salixalba: 0.50% zinc sulphate hexahydrate: 0.20%

The aqueous-alcoholic extract of Allium cepa was prepared by picking,cleaning and milling the Allium, macerating in 96° alcohol for 48 hoursin the cold, filtering through a 0.22-micron filter, collecting thealcoholic filtrate and adjusting to 30° alcohol.

The aqueous-alcoholic extract of Citrus lemon was prepared by picking,cleaning and milling the Citrus, macerating in 96° alcohol for 48 hoursin the cold, filtering through a 0.22-micron filter, collecting thealcoholic filtrate and adjusting to 30° alcohol.

A master solution containing the aqueous-alcoholic extracts of Alliumand Citrus was prepared by simple mixing, then the aqueous extract ofSalix alba and the zinc sulphate hexahydrate were added to this mastersolution to give the required combined extract.

Example 3

A food supplement was prepared containing:

a dry extract of Allium cepa: 87.04% a dry extract of Citrus lemon:11.96% a dry extract of Paullinia cupana: 0.50% a dry extract ofTheobroma cacao: 0.50%

This was obtained by adding an aroma to the composition obtained inExample 1 and then freeze-drying the mixture to give a powder whichcould be used directly as a food supplement.

Example 4

A cosmetic lotion for scalp treatment was prepared from the followingcomponents:

composition obtained in Example 1  21 ml excipient qsp (includingperfume/aroma) 100 ml

The lotion was prepared by simple mixing of the composition obtained inExample 1 and an excipient.

Example 5

A medicinal lotion for scalp treatment was prepared from the followingcomponents

composition obtained in Example 2  40 ml excipient qsp (includingperfume/aroma) 100 ml

The lotion was prepared by simple mixing of the composition obtained inExample 2 and an excipient.

Example 6

Tablets with the following formulation were prepared:

composition obtained in Example 3 100 mg excipient qsp (includingperfume/aroma) 300 mg

(excipient details: lactose, talcum, starch, magnesium stearate)

Example 7

An ointment for medicinal use was prepared as follows:

composition obtained in Example 3 5 ml excipient qsp (includingperfume/aroma) 100 g1.

1) Study of Anti-Hair Loss Effectiveness Using the PhototrichogramMethod with Hair Treatment Used Under Normal Conditions of Use During 12Consecutive Weeks

20 male volunteers, aged from 35-55 and having slight to moderatebaldness corresponding to types II-IV of the Hamilton scale were treatedusing the composition of example 4 (Hamilton scale: type 1: slightlyreceding hairline, type II: receding hairline at the temples andthinning of the region of the vertex, type III: meeting of the temporalrecession and the vertex bald spot, type IV: baldness except for regionof the temples, type V hair loss in the vertex).

The protocol was the following:

Day 1: location of the temporal site, cross-sections of hair at thepoint of emergence from the scalp, macrophotography of the regionstudied,

Days 1-2: no application of product, no shampooing,

Day 3: new macrophotography of the same region as at day 1 and beginningof treatment:

Days 3-42: application of the product to the scalp twice a day (2-3sprays on each occasion),

Day 42: evaluation of capillary and skin tolerance, location of thetemporal site, cross sectioning of the hair at the point of emergencefrom the scalp, macrophotography of the region studied,

Days 42 - 43: no application of product and no shampooing,

Day 44: fresh macrophotography of the same region as at day 1,

Days 44-84 application of the product understudy to the scalp twice aday (2-3 sprays on each occasion), to the site of cross-section of thehair at the point of emergence from the scalp,

Day 84: evaluation of capillary and skin tolerance, location of thetemporal site of the region studied, cross sectioning of the hair at thepoint of emergence from the scalp, macrophotography of the regionstudied,

Days 84-85: no application of the product and no shampooing,

Day 86: new macrophotography of the same region as at day 1.

The study showed:

-   -   a significant anti-hair loss effectiveness after six weeks of        treatment: statistically significant increase in the A/T ratio        (anagenic/telogenic ratio) of +44.91%    -   significant anti-hair loss effectiveness after 12 weeks of        treatment: statistically significant increase in the A/T ratio        (anagenic/telogenic ratio) of +46.78%    -   good clinical tolerance: no skin reaction was observed during        dermatological examination    -   good subjective clinical tolerance: one volunteer did        nevertheless describe experiencing cutaneous discomfort.

2) Evaluation of Angeogenesis Activity of the Compounds of Examples 1and 2

The product of the invention was tested on Angiokit plates. Usingwell-known tests, the development of endothelial cells in co-culturewith fibroblasts was checked, and the formation of capillary structures(tubules) was observed. The product tested at differing concentrationswas introduced onto each plate into certain wells. Certain wellsadditionally received an activator (VEGF) while other wells received aninhibitor (Suramine). Some wells acted as controls.

The nutrient medium was changed at days 3, 4, 7, 10 and 12 and the testwas terminated at day 15.

The results observed on day 15 showed that the product has pronouncedangeogenic activity.

The invention claimed is:
 1. A method to regulate and/or stabilize conditions affecting skin of a subject, comprising: administering to the subject in need thereof a composition comprising from 65% to 93% of an aqueous-alcoholic extract of Allium species, from 5% to 33% of an aqueous-alcoholic extract of Citrus species, from 0.25% to 2.5% of an aqueous-alcoholic extract of Paullinia species and from 0.25% to 2.5% of an aqueous-alcoholic extract of Theobroma species, wherein the treatment regulates and/or stabilizes the conditions affecting the skin of the subject.
 2. The method of claim 1, further comprising preparing medicines comprising the composition for the treatment of dermatosis, disorders of cicatrisation, disorders of keratinisation, keratotic lesions, or circulatory or vasomotor disorders.
 3. The method of claim 2, further comprising preparing medicines comprising the composition for the treatment of dermatosis due to various cutaneous bacterial or viral infections, ageing of the skin, bleaching or whitening of the skin, vitiligo, acrodermatitis, light-induced (actinic) ageing of the skin and various conditions related to sunrays (photodermatosis), acne of any origin (vulgaris, inflammatory or papulo pustule), acne rosacea, lupus erythematosus, sensitive skin, insect stings, oily or dry skin, seborrheic disorders, alopecia of any origin, hair loss, psoriasis or parapsoriasis, dyshidrosis, warts or corns, scabies, angular cheilitis, or oedema.
 4. The method of claim 2, further comprising preparing medicines comprising the composition for the treatment of cicatrisation of wounds, affections of any origin, burns, blotchiness, Behçet's disease, cutaneous porphyria, angiomas or malignant metastases.
 5. The method of claim 2, further comprising preparing medicines comprising the composition for the treatment of disorders of keratinisation, keratotic lesions, hyperkeratosis, including keratoderma, dyskeratosis, Darier's disease, parakeratosis, ichthyosis, eczema, neurodermatitis, erythroderma, lichenification, scaly dermatosis, prurigo, keloid, or pustulosis.
 6. The method of claim 2, further comprising preparing medicines comprising the composition for the treatment of circulatory or vasomotor disorders, including functional signs during haemorrhoidal pressure, thrombotic affections, symptoms associated with veno-lymphatic insufficiency, heavy legs, or paresthesia.
 7. The method of claim 1, wherein the Allium species is Allium cepa, the Citrus species is Citrus lemon, the Paullinia species is Paullinia cupana, and the Theobroma species is Theobroma cacao.
 8. A method to treat a condition affecting skin, scalp, or external parts of a body of a subject, the method comprising: administering to the subject in need thereof one to three times a day a composition comprising from 65% to 93% of an aqueous-alcoholic extract of Allium species, from 5% to 33% of an aqueous-alcoholic extract of Citrus species, from 0.25% to 2.5% of an aqueous-alcoholic extract of Paullinia species and from 0.25% to 2.5% of an aqueous-alcoholic extract of Theobroma species.
 9. The method of claim 8, wherein the condition being treated is selected from a group consisting of: dermatosis due to various cutaneous bacterial or viral infections, ageing of the skin, bleaching and whitening of the skin, vitiligo, acrodermatitis, light-induced (actinic) ageing of the skin and various conditions related to sunrays (photodermatosis), acne of any origin, acne vulgaris, inflammatory acne, papulo pustule, acne rosacea, lupus erythematosus, sensitive skin, insect stings, oily or dry skin, seborrheic disorders, alopecia of any origin, hair loss, pityriasis capitis, pelada, sensitive scalp, greasy hair, psoriasis and parapsoriasis of the scalp, dyshidrosis, warts and corns, scabies, angular cheilitis and oedema, any disease capable of affecting the nails, and combinations thereof.
 10. The method of claim 8, wherein the condition occurs on the scalp of the subject and is selected a group consisting of: dandruff, signs of ageing of the scalp, alopecia, hair loss, pityriasis capitis, pelada, sensitive scalp, greasy hair, psoriasis and parapsoriasis of the scalp, dyshidrosis, and combinations thereof.
 11. The method of claim 8, wherein the condition is a disorder of the nails of the subject.
 12. The method of claim 8, wherein the condition being treated is selected from a group consisting of: disorders of the scalp, dermatosis, disorders of cicatrisation, disorders of keratinisation, keratotic lesions, circulatory and vasomotor disorders, and combinations thereof.
 13. The method of claim 8, wherein the condition being treated is selected from a group consisting of: cicatrisation of wounds, skin affections of any origin, burns, blotchiness, Behçet's disease, cutaneous porphyria, angiomas and malignant metastases, and combinations thereof.
 14. The method of claim 8, wherein the condition being treated is selected from a group consisting of: disorders of keratinisation, keratotic lesions, hyperkeratosis, keratoderma, dyskeratosis, Darier's disease, parakeratosis, ichthyosis, eczema, neurodermatitis, erythroderma, lichenification, scaly dermatosis, prurigo, keloid, pustulosis, and combinations thereof.
 15. The method of claim 8, wherein the condition being treated is selected from a group consisting of: circulatory and vasomotor disorders, functional signs during haemorrhoidal pressure, thrombotic affections, symptoms associated with veno-lymphatic insufficiency, and combinations thereof.
 16. The method of claim 8, wherein the Allium species is Allium cepa, the Citrus species is Citrus lemon, the Paullinia species is Paullinia cupana, and the Theobroma species is Theobroma cacao.
 17. A method to treat a condition affecting skin, scalp, or external parts of a body of a subject, the method comprising: administering to the subject in need thereof a composition comprising from 65% to 93% of an aqueous-alcoholic extract of Allium species, from 5% to 33% of an aqueous-alcoholic extract of Citrus species, from 0.25% to 2.5% of an aqueous-alcoholic extract of Paullinia species and from 0.25% to 2.5% of an aqueous-alcoholic extract of Theobroma species, wherein a daily dose of the composition is about 5 to 500 mg.
 18. The method of claim 17, wherein the composition is administered to the subject at a daily dose of about 0.05 mg/kg to 10 mg/kg.
 19. The method of claim 17, wherein the condition being treated is selected from a group consisting of: dermatosis due to various cutaneous bacterial or viral infections, ageing of the skin, bleaching and whitening of the skin, vitiligo, acrodermatitis, light-induced (actinic) ageing of the skin and various conditions related to sunrays (photodermatosis), acne of any origin, acne vulgaris, inflammatory acne, papulo pustule, acne rosacea, lupus erythematosus, sensitive skin, insect stings, oily or dry skin, seborrheic disorders, warts and corns, scabies, angular cheilitis and oedema, disorders of the scalp, dandruff, signs of ageing of the scalp, alopecia, hair loss, pityriasis capitis, pelada, sensitive scalp, greasy hair, psoriasis and parapsoriasis, dyshidrosis, scabies, angular cheilitis and oedema, any disease capable of affecting the nails, disorders of cicatrisation, disorders of keratinisation, keratotic lesions, circulatory and vasomotor disorders, and combinations thereof.
 20. The method of claim 16, wherein the Allium species is Allium cepa, the Citrus species is Citrus lemon, the Paullinia species is Paullinia cupana, and the Theobroma species is Theobroma cacao. 